Key takeaways
CQC powers extend beyond regulatory action
Understand when poor care crosses into criminal liability
Breaches can lead to severe penalties
Fines may reach millions even without actual harm
Early legal advice is critical
Respond promptly to pace notices to protect your position
CQC Prosecutions: when unsafe care and treatment becomes criminal
The Care Quality Commission (CQC) is the independent regulator of health and adult social care in England. It aims to make sure health and social care services provide people with safe and effective care and encourage services to improve. Where poor care is identified, the CQC can use its powers to take action, including issuing notices to set out what improvements the care provider must make; making changes to a care provider’s registration; placing a provider in special measures; and holding care providers to account by issuing cautions or fines.
Further, since 1 April 2015, the CQC has had the power to prosecute health and social care providers in England, including organisations or individuals (such as registered managers) from the public and private sectors. Such prosecutions must be brought within three years of the date of the alleged offence and may relate to an alleged failure to comply with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 or the Care Quality Commission (Registration) Regulations 2009.
From our experience, the most relevant offences concern breaches of:
Regulation 12(1) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 – failure to provide safe care and treatment to service users;
Regulation 22(2) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 – that the failure above results in avoidable harm (whether of a physical or psychological nature) or a significant risk of exposure to avoidable harm.
It is important to note that, even if no actual harm has occurred, an organisation or individual can still be found guilty of an offence.
An investigation by the CQC may lead to a Police and Criminal Evidence Act 1984 (PACE) Notice, which is issued to ensure the ‘suspect’ (i.e. the organisation or individual accused of the offence) understands the nature of the offence and why they are a suspect, and has the opportunity either to attend an interview in person, make no comment on the allegations, or make written representations in lieu of attending an interview.
The CQC will then consider whether to proceed with the prosecution based on (a) whether there is enough evidence against the proposed defendant; and (b) whether it is in the public interest for them to bring the case to court.
In the criminal courts, the burden of proof is usually on the prosecution; however, for CQC prosecutions under Section 22(4) of the Health and Social Care Act, the burden of proof is reversed and it is for the defendant to prove,
"that they took all reasonable steps and exercised all due diligence to prevent the breach of any of those regulations that has occurred”.
The consequences of a prosecution on an organisation or individual are significant, including serious reputational damage, a criminal conviction, and potentially a very significant fine ranging from £1m - £6m.
In the most recently reported prosecution brought by the CQC, which has been widely commented on in the press, an NHS Trust admitted six counts of failing to provide safe care and treatment to three babies and their mothers in 2021, resulting in a fine of £1.6 million (which was reduced from £5.5 million taking account of the Trust’s financial position and guilty pleas) plus prosecution costs.
During the sentencing hearing, the judge noted that,
"there were systems in place but there were so many procedures where guidance was not followed or adhered to… The failures in combination amounted to systemic failures in the provision of care and support.”
This is the second successful CQC prosecution of this Trust – the first having also related to a failure to provide safe care and treatment to a baby and her mother (in 2019), leading to a £800,000 fine.
While the sentencing judge considered the fact that the Trust is a publicly-funded body and currently operating at a deficit, she commented:
"I can’t ignore the negative impact this will have… but the significant financial penalty has to be fixed to mark the gravity of these offences and hold the trust to account for their failings”.

